Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-11-13
2003-12-09
Hayes, Michael J. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S110000
Reexamination Certificate
active
06659984
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The subject invention relates to a blood collection set having a needle cannula and a shield that can be driven in opposite directions to safely shield the needle cannula.
2. Description of the Related Art
A prior art blood collection set includes a small diameter needle cannula having a pointed distal end and a proximal end mounted to a thermoplastic hub. Portions of the blood collection set near the hub may be provided with a pair of flexible wings. The wings can be folded into face-to-face engagement with one another to facilitate digital manipulation of the small needle cannula. The wings then can be folded away from one another and taped into face-to-face engagement with the skin of the patient near a puncture site. The prior art blood collection set further includes a flexible plastic tube that has one end connected to the hub and an opposed end connected to a fitting. The fitting can be placed in communication with a reservoir to which collected blood may be directed.
The needle cannula of the prior art blood collection set typically is shielded prior to and after use to prevent accidental sticks. Needle shields used with prior art blood collection sets have taken many forms. Typically, a prior art blood collection set is packaged with a rigid tubular cap telescoped over the needle cannula to prevent accidental sticks prior to use. This tubular cap is removed from the needle cannula immediately prior to use of the blood collection set. Most prior art blood collection sets further include a second shield that is telescoped over the needle cannula and hub. The second shield may include at least one slot through which wings of the prior art hub may extend. Thus, the medical technician who uses the prior art blood collection set will hold the wings of the needle hub in one hand and the shield in the other hand after removing the needle cannula from the patient or blood donor. The wings then are slid proximally relative to the shield, thereby drawing the needle cannula into the shield. Some prior art shields are configured to engage the wings when the needle cannula has been shielded to make a re-exposure of the needle cannula difficult.
The digital manipulation that is required to shield the used needle cannula of a prior art blood collection set creates the potential for generating the accidental needle stick that the shield is intended to avoid. In particular, it is undesirable to rely upon a shielding that requires two hands to be moved in opposite directions in proximity to the point of a used needle cannula. Accordingly, the inventors herein have recognized the desirability of providing an automatically shieldable needle cannula for a blood collection set.
SUMMARY OF THE INVENTION
The subject invention relates to a blood collection set which comprises a needle cannula having a proximal end, a pointed distal end and a lumen extending therebetween. The blood collection set further includes a hub that may be molded from a thermoplastic material. The hub includes a proximal end, a distal end and a passage extending continuously therebetween. The distal end of the hub is securely mounted to the proximal end of the needle cannula. Thus the lumen through the needle cannula communicates with the passage through the hub. The hub further includes an outwardly extending actuator disposed at a location near the distal end of the hub. The hub further includes a dorsal fin that extends outwardly at a location spaced slightly proximally from the actuator. The dorsal fin and the actuator are disposed in a common radially aligned plane of the hub. Additionally, the dorsal fin can be deflected about its connection to the hub for engaging the actuator.
The blood collection set may further include a length of flexible tubing having opposed proximal and distal ends. The distal end of the flexible tubing may be connected to the proximal end of the hub such that the lumen through the needle cannula and the passage through the hub both communicate with the passage through the flexible tubing. The flexible tubing further includes a proximal end that may be connected to a fitting. The fitting may comprise a needle cannula that enables the blood collection set to be placed in communication with a reservoir for receiving a sample of blood. The tubing and the fitting may be of conventional design.
The blood collection set may further include a substantially rigid generally tubular safety cap mounted over the needle cannula for protection against accidental needle sticks prior to use of the blood collection set. The safety cap may include a proximal end that is frictionally engaged with the hub. The rigid tubular safety cap may be removed immediately prior to use of the blood collection set.
The blood collection set further includes a safety shield that is movable axially relative to the hub and cannula from a position, where the needle cannula is exposed, to a position, where the needle cannula is safely shielded. Biasing means are provided between the shield and the hub for urging the shield and the hub in opposite directions for shielding the needle. The biasing means may be a coil spring that surrounds a portion of the hub. A shield includes a slot extending longitudinally from a location near the proximal end to a location spaced slightly proximally from the distal end. The slot is dimensioned to slidably receive portions of the dorsal fin adjacent the hub. Portions of the slot near the proximal end of the shield define a restriction for gripping the dorsal fin and holding the dorsal fin at the proximal end of the slot. The safety shield also includes a retention opening between the slot and the extreme distal end of the safety shield. The retention opening is dimensioned to releasably engage the actuating projection formed on the hub.
The blood collection set initially has the needle cannula projecting distally beyond the shield. However, the safety cap is securely mounted over the needle cannula to prevent accidental sticks prior to use of the blood collection set. The safety cap then can be removed to permit use of the blood collection set substantially in a conventional manner. After use, the dorsal fin can be deflected distally and into engagement with the actuator. Contact between the dorsal fin and the actuator will urge the actuator out of the retention opening in the safety shield. Thus, the biasing means will drive the hub and the safety shield in opposite direction such that the safety shield surrounds the needle cannula. In some embodiments, the user may grip the dorsal fin such that the safety shield is driven forwardly or distally into surrounding relationship around the needle cannula. In other embodiments, the safety shield may include a pair of wings extending transversely from the safety shield. The wings may be gripped by a health care worker or taped to the patient. In this situation, the hub and the needle cannula will be driven rearwardly or proximally relative to the shield for retracting the needle cannula into the shield.
REFERENCES:
patent: 5219339 (1993-06-01), Saito
patent: 5330438 (1994-07-01), Gollobin et al.
patent: 5498241 (1996-03-01), Fabozzi
patent: 5501672 (1996-03-01), Firth et al.
patent: 5779679 (1998-07-01), Shaw
patent: 0475857 (1992-03-01), None
patent: WO98/42393 (1998-10-01), None
patent: WO98/48883 (1998-11-01), None
patent: WO00/25845 (2000-05-01), None
patent: WO00/37125 (2000-06-01), None
Crawford Jamieson William Maclean
Livanos Stefanie
Becton Dickinson and Company
Hayes Michael J.
Rittman, Esq. Scott J.
Thomas, Esq. Nanette S.
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